Product Wiki · Recalls · U.S. FDA — Device Enforcement

C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System — recall Z-0630-2020

U.S. FDA — Device Enforcement · United States · 2019-10-21 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0630-2020
Date of alert
2019-10-21
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Integra LifeSciences Corp.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
60905204
Reported risk: The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operators manual states 30 minutes for the minimum Dry Time for the 36 kHz Sterilization Tray and 36 kHz Components but 40 minutes is required for complete drying.
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.